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Last Updated: November 6, 2025

ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Ancef In Sodium Chloride 0.9% In Plastic Container, and what generic alternatives are available?

Ancef In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ancef In Sodium Chloride 0.9% In Plastic Container

A generic version of ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER was approved as cefazolin sodium by SANDOZ on December 9th, 1988.

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  • What is the 5 year forecast for ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER?
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Summary for ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cefazolin sodium INJECTABLE;INJECTION 050566-001 Jun 8, 1983 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cefazolin sodium INJECTABLE;INJECTION 050566-002 Jun 8, 1983 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Ancef in Sodium Chloride 0.9% in Plastic Container

Last updated: July 31, 2025


Introduction

Ancef (cefazolin sodium), a first-generation cephalosporin antibiotic, remains a significant staple in antimicrobial therapy. When formulated as Sodium Chloride 0.9% in a plastic container, it serves as a sterile, isotonic solution administered intravenously to treat a broad spectrum of bacterial infections. The current market landscape for Ancef in this formulation hinges on pivotal factors such as rising antimicrobial resistance, clinical preference for cephalosporins, manufacturing advancements, and evolving healthcare protocols.


Market Overview and Growth Drivers

Global Market Size and Segmentation

The global pharmaceutical injectable antibiotics market, valued at approximately USD 35 billion in 2022, projects a compound annual growth rate (CAGR) of 4-6% through 2030 [1]. Cefazolin accounts for a significant share, especially in North America and Europe, driven by its efficacy, safety profile, and cost-effectiveness.

Ancef's formulation in Sodium Chloride 0.9% in plastic containers links directly to hospital inpatient settings where IV administration is standard. This segment represents over 60% of the total cefazolin market, with outpatient and long-term care segments gaining momentum due to the convenience of pre-filled, ready-to-use plastic containers.

Clinical Demand and Therapeutic Use Cases

Cefazolin's broad-spectrum activity against MSSA (methicillin-sensitive Staphylococcus aureus) and other Gram-positive bacteria positions it as a first-line agent in surgical prophylaxis, skin infections, and respiratory infections. The increasing prevalence of surgical procedures worldwide and the emphasis on prophylactic antibiotics predominantly bolster demand.

Furthermore, the recent surge in antimicrobial resistance necessitates the use of reliable antibiotics like cefazolin, especially in hospital settings where resistant strains are prevalent.

Impact of COVID-19 Pandemic

The COVID-19 pandemic temporarily disrupted pharmaceutical supply chains but bolstered demand for antibiotics in bacterial co-infections and secondary infections in hospitalized patients [2]. The pharmaceutical industry responded with increased manufacturing efforts, which are expected to sustain post-pandemic.


Market Dynamics

Supply Chain and Manufacturing Factors

Manufacturing of Ancef in Sodium Chloride 0.9% involves complex sterile processes with stringent regulatory oversight. Companies such as Pfizer (which produces Ancef) have invested heavily in GMP-compliant manufacturing facilities. The rising costs of raw materials (e.g., cefazolin active pharmaceutical ingredients, plastic containers) directly influence product pricing and margins.

Additionally, increasing focus on single-use, pre-filled plastic containers enhances convenience and safety but demands compliance with evolving regulations around device packaging and sterilization. Supply chain disruptions, especially for raw materials, have prompted manufacturers to diversify sourcing and buffer inventories.

Regulatory Landscape and Patent Expirations

While Pfizer’s patent protections for Ancef have largely expired globally, leading to generic proliferation, regulatory hurdles with different markets influence product availability and competition dynamics [3]. Stringent regulatory requirements for injectable sterility and stability further shape market entry and product life cycles.

Pricing and Reimbursement Policies

Pricing strategies are sensitive to healthcare reimbursement environments. Developed markets maintain favorable reimbursement policies for hospital-administered antibiotics, supporting stable margins. Conversely, emerging markets often face price pressures, prompting local manufacturers to explore cost efficiencies.


Financial Trajectory

Revenue Trends and Forecasts

Pfizer and other manufacturers project moderate but steady growth in Ancef sales, driven by increased prophylactic use and a comprehensive product portfolio with Cefazolin. Analysts forecast a CAGR of 3-5% within the injectable antibiotic segment over the next five years.

In key markets, revenue growth is complemented by strategic expansion into outpatient infusion centers, where ready-to-use plastic containers simplify dispensing and administration.

Market Penetration and Competitive Landscape

Generic cefazolin formulations occupy significant market share, fostering price competition but also pressuring margins for branded products like Ancef. The differentiation via formulation stability, packaging, and supply chain reliability will determine market share retention.

Emerging innovations, such as lyophilized formulations for extended shelf life and alternative delivery systems, could influence future revenues.

Profitability and Investment Outlook

Investment in manufacturing technology, such as automated sterile filling lines and advanced plastic sterilization processes, is expected to improve operating efficiencies. Profitability margins for Ancef in Sodium Chloride 0.9% are projected to remain stable amid rising raw material costs, as manufacturers leverage scale and process innovation.


Market Challenges and Opportunities

Challenges:

  • Antimicrobial stewardship programs emphasizing judicious antibiotic use constrict growth potential.
  • Pricing pressures from generic manufacturers and competitive products.
  • Regulatory hurdles in maintaining compliance for sterile formulations.

Opportunities:

  • Expansion into emerging markets with unmet demand.
  • Innovation in packaging, such as pre-filled, multi-dose containers, enhancing safety.
  • Formulation improvements to enhance stability and shelf life.

Conclusion and Outlook

The financial trajectory for Ancef in Sodium Chloride 0.9% in plastic container remains positive, supported by persistent clinical demand, expanding infrastructural adoption, and strategic product innovation. While price competition and regulatory hurdles persist, the overall market dynamics favor steady growth, especially in hospital inpatient settings and emerging healthcare markets.


Key Takeaways

  • The global injectable antibiotic market, notably cefazolin, is projected to grow at 4-6% CAGR over the next decade due to clinical demand and healthcare infrastructure expansion.
  • Ancef’s market is influenced by demand for surgical prophylaxis, antimicrobial resistance patterns, and clinical guidelines favoring cephalosporins.
  • Manufacturing complexities, regulatory standards, and raw material costs are critical factors affecting market stability and profitability.
  • Generic competition exerts downward pressure on prices, but innovations in packaging and formulation can offer differentiation.
  • Strategic penetration into emerging markets offers considerable growth potential amid increasing healthcare access.

FAQs

  1. What factors influence the price of Ancef in Sodium Chloride 0.9% in plastic containers?
    Price is primarily affected by raw material costs, manufacturing complexity, regulatory compliance costs, competitive landscape, and reimbursement policies.

  2. How does antimicrobial resistance impact Ancef demand?
    Rise in resistant bacterial strains emphasizes the need for effective antibiotics like cefazolin, sustaining demand, especially in hospital settings. However, resistance may also lead to increased use of combination therapies, slightly altering the market landscape.

  3. What role does innovation in packaging play in Ancef’s market growth?
    Innovative packaging, such as pre-filled, multi-dose plastic containers, improves safety, convenience, and shelf life, offering competitive advantages and expanding use in outpatient and emergency settings.

  4. Are there regulatory challenges unique to sterile injectable antibiotics?
    Yes. Strict compliance with sterile manufacturing practices, stability, and sterilization validation are mandatory, with evolving standards potentially affecting market entry and ongoing compliance costs.

  5. What emerging markets present growth opportunities for Ancef?
    Regions such as Southeast Asia, Latin America, and parts of Africa, with expanding healthcare infrastructure and limited local antibiotic production, offer significant growth prospects.


References

  1. [Market Research Future, "Pharmaceutical Injectable Antibiotics Market," 2022]
  2. [WHO, "Antimicrobial resistance: global report on surveillance," 2014]
  3. [U.S. Food and Drug Administration, "Drug Approvals and Patent Listings," 2022]

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